Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research.

Abstract:

:This manuscript explores the ethics of human inoculation experiments in young healthy adults with wild-type severe acute respiratory sydrome coronavirus 2 (SARS-CoV-2) as a tool to evaluate vaccine efficacy in the context of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, and in the context of dose-response relationships with infectious agents. Despite societal pressure to develop a SARS-CoV-2 challenge model to evaluate vaccines, we argue that there are substantial risks that cannot be adequately defined because the dose of SARS-CoV-2 that causes severe disease in young adults is unknown. In the absence of curative therapy, even if a volunteer consents, longstanding ethical codes governing human subjects research preclude the conduct of such experiments.

journal_name

Open Forum Infect Dis

authors

Spinola SM,Broderick C,Zimet GD,Ott MA

doi

10.1093/ofid/ofaa615

subject

Has Abstract

pub_date

2020-12-28 00:00:00

pages

ofaa615

issue

1

issn

2328-8957

pii

ofaa615

journal_volume

8

pub_type

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